“During the presentation, we will discuss materials that can have an impact on test results, which specific tests to use, and how to confirm test results,” said Rollins. “For those who want to dig a little deeper, we will also be conducting free biocompatibility consultations.”

During the consultations, participants can go over any biocompatibility topic they wish with Rollins. Some suggested topics may include:

An overview of the most common biocompatibility tests and what materials could impact the results

How FDA and other regulatory agencies will interpret your results or test selection

How the new FA Draft Guidance might impact your future testing

How to categorize you device according to ISO 10993

Materials Characterization for Medical Devices per ISO 10993-17,18:

The correct way to extract your device to look for extractables and leachables

What tests to run to identify and quantify the compounds

How to determine the potential toxicological impact of the compounds

What To Do If You Fail A Compatibility Test:

How to confirm the result

How to trouble shoot and ways to improve you device

How to justify a failure

About Nelson Laboratories: Nelson Laboratories is a leading provider of full, life-cycle microbiology testing services. We are known for exceptional quality, but we look beyond the testing process and partner with you to achieve your long-term business goals. It’s what we call The Science of Success™. Learn how we can help move your products to market quickly and safely. Visit http://www.nelsonlabs.com.